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Objective: To compare the clinical effectiveness of two treatment strategies for active rheumatoid arthritis (RA) refractory to conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs): starting TNF inhibitors (TNFIs) or changing csDMARDs. Methods: We used two nationwide Korean RA registries for patient selection. TNFI users were selected from the BIOPSY, which is an inception cohort of RA patients starting biologic DMARDs. As a control group, we selected RA patients with moderate or high disease activity from the KORONA database whose treatment was changed to other csDMARDs. After comparing baseline characteristics between the two groups in either unmatched or propensity score matched cohorts, we compared potential differences in the 1-year remission rate as a primary outcome and changes in HAQ-DI and EQ-5D scores as secondary outcomes. Results: A total of 356 TNFI starters and 586 csDMARD changers were identified from each registry as unmatched cohorts, and 294 patients were included in the propensity score matched cohort. In the intention-to-treat analysis, TNFI starters had higher 1-year remission rates than csDMARD changers in both unmatched (19.1 vs. 18.4%, p < 0.01) and matched cohorts (19.7 vs. 15.0%, p < 0.01). In per protocol analysis, TNFI starters had much higher remission rates in unmatched (37.2 vs. 28.0%, p = 0.04) and matched cohorts (35.4 vs. 19.1%, p = 0.04). However, in matched cohorts, no significant differences were observed between two groups in HAQ-DI and EQ-5D scores. Conclusions: We compared the clinical effectiveness of the two treatment strategies for active RA refractory to csDMARDs. TNFI starters showed higher 1-year remission rates than csDMARD changers. [ABSTRACT FROM AUTHOR]

We aimed to investigate the proportion of atypical femoral fractures (AFF) among Korean femoral fracture patients and examined the factors associated with the development of AFF. Between 2003 and 2013, 607 female patients with low-energy femoral fractures who were hospitalized at a single university hospital were retrospectively enrolled in this study. Patients were classified into two groups according to the fracture site: Patients with subtrochanteric or diaphyseal femoral fractures were included in the AFF group, while patients with intertrochanteric or neck fractures were included in the typical femoral fracture (TFF) group. After comparing clinical and radiographic characteristics between groups, we used multivariable logistic regression analysis to explore risk factors for AFF. Thirty patients (4.9 %) with AFF and 577 patients (95.1 %) with TFF were identified. The AFF group was younger than the TFF group ( p < 0.01), and more patients with AFF were treated with bisphosphonate (BP) ( p < 0.01) or proton-pump inhibitor ( p = 0.02). When comparing the radiographic parameters, the AFF group tended to have a higher cortical thickness index ( p = 0.02) and lateral-to-medial cortex ratio ( p < 0.01). After adjusting for clinical variables, BP use (OR 8.09, CI 3.09-21.19) and younger age (OR 1.06, CI 1.01-1.11) were associated with AFF. The proportion of AFF was 4.9 % among patients with femoral fractures. Younger age and use of BP before fracture increased the risk of development of AFF in Korean patients. [ABSTRACT FROM AUTHOR]

To investigate changes in the risk for serious infections (SIs) over time in Japanese rheumatoid arthritis (RA) patients treated with tumor necrosis factor inhibitors (TNFIs). This prospective cohort study included Japanese RA patients who began treatment with a TNFI from 2005 to 2007 (2005 group, n = 716, 634.2 patient years [PY]) and from 2008 to 2011 (2008 group, n = 352, 270.1 PY) at the time or after their enrollment in the registry of Japanese RA patients on biologics for long-term safety (REAL) database. Patients were observed for 12 months or until discontinuation of their initial TNFI in the REAL database. Drug discontinuation reasons and retention rates were analyzed. Incidence rates of serious adverse events (SAEs) were calculated with 95 % confidence intervals (CIs). The Cox proportional hazard model was applied to estimate the risk for SIs. The retention rate in the 2008 group was significantly lower than the 2005 group ( p < 0.001). Discontinuation rates due to lack of efficacy or good control for the 2008 group were significantly higher than the 2005 group ( p < 0.001). The crude incidence rate ratios comparing the 2008 group with the 2005 group for SAEs were 0.93 (95 % CI 0.65-1.34) and for SIs were 0.50 (0.24-1.03). The 2008 group had significantly lower risk for SIs than the 2005 group after adjusting for covariates (hazard ratio: 0.43 [0.20-0.93]). These results indicate significant decrease of the risk for SIs with TNFI treatment over time; this may be explained by evidence-based risk management of RA patients given TNFIs. [ABSTRACT FROM AUTHOR]

Several studies of rheumatoid arthritis (RA) incidence and prevalence indicate that occurrence of the disease varies significantly among different populations. We aimed to estimate the prevalence and incidence of RA in South Korea. We used Korean National Health Insurance (NHI) claims data to estimate the prevalence of RA in 2007-2009 and the incidence of RA in 2008. On the basis of our previous validation study, the presence of RA was defined by the diagnostic code for RA with biologic or non-biologic disease-modifying anti-rheumatic drugs in the same claim in each year. To estimate the incidence of RA, we identified cases of RA in 2008 and set the 12-month period prior to 2008 as a disease-free period. Among the incident case of 2008, only patients who continued treatment in 2009 were defined as true incident case of RA in 2008. The corresponding prevalence estimates were 0.26 % (95 % CI 0.25-0.27) in 2006, 0.27 % (95 % CI 0.26-0.28) in 2007, and 0.27 % (95 % CI 0.26-0.28) in 2008. The incidence of RA in 2008 was estimated at 42/100,000 (95 % CI 29.3-54.7) in the general population of South Korea. Data gathered nationwide through the NHI yielded estimates of RA prevalence and incidence in South Korea. This study is the first report of nationwide prevalence and incidence of South Korea and those are comparable to values for other countries in Asia. [ABSTRACT FROM AUTHOR]

The aim of the study was to identify factors influencing the health-related quality of life (HR-QOL) for Korean RA patients and factors associated with each dimension of the EQ-5D. Two hundred and twenty-five RA patients were recruited from one University Hospital in Seoul, South Korea. Their clinical and socio-demographic data were widely collected by means of interviews, self-administered questionnaires, and clinical examinations. Multiple logistic regression analyses were performed to determine the factors influencing QOL and factors associated with each dimension of the EQ-5D. The mean EQ-5D utility observed for Korean RA patients was 0.60 (−0.29 to 1.0). Functional disability measured with Health Assessment Questionnaire (OR = 10.0, CI 2.8-34.5), disease activity score (DAS) 28 (OR = 2.6, CI 1.4-4.9), and pain VAS (OR = 2.2, CI 1.2-4.1) was three main factors influencing on QOL of RA patients. Although the functional disability consistently showed significant associations with all dimensions, various factors were associated with the each five specific dimension of EQ-5D. Pain (OR = 2.5, CI 1.4-4.6), history of hospitalization (OR = 2.1, CI 1.0-4.3), and men (OR = 2.6, CI 1.0-6.8) were associated with lower QOL in mobility. Use of alternative medicine (OR = 2.0, CI 1.1-3.7) and disease activity (OR = 3.1, CI 1.7-5.7) were associated with lower self-care QOL. For the patients with discomfort in usual activity, pain (OR = 4.7, CI 2.4-9.2) and the presence of anemia (OR = 2.3, CI 1.2-4.5) were major influencing factors. Higher disease activity (OR = 4.5, CI 1.0-21.2) and pain (OR = 3.3, CI 1.9-5.8) were associated with the pain/discomfort dimension of EQ-5D, and the pain (OR = 3.3, CI 1.9-5.8) was an independent associating factor of anxiety/depression. The strongest determinants of lower QOL in Korean RA patients were functional disability, higher disease activity, and subjective pain. However, various factors are influencing on the QOL for RA patients according to aspects of QOL. It suggested that clinicians should pay more attention to other factors of RA patients as well as clinical remission to improve their QOL. [ABSTRACT FROM AUTHOR]

The aim of this study is to evaluate tumor necrosis factor (TNF) inhibitor persistence and the impact of comorbidity on treatment persistence in patients with rheumatoid arthritis (RA). In a Korean National Health Insurance claims database, patients with a diagnosis code of RA (M05 or M06) who started TNF inhibitor therapy between July 1, 2007 and June 30, 2008 were enrolled. The study cohort was followed until December 31, 2009. Persistence was examined using Kaplan-Meier survival analysis, and multivariate Cox proportional hazard models were developed to examine the potential impact of comorbidities on drug persistence. A total of 388 patients were enrolled in the study cohort. The mean persistence rate in the overall population was 61% at 18 months. Drug survival rates for adalimumab and etanercept at 6 months were 82 and 85%, respectively, and 73 and 78%, respectively, at 12 months. Charlson comorbidity index (CCI) scores and comorbidities such as diabetes, chronic pulmonary disease, mild liver disease, and depression at initiation were not related with drug persistence, while peptic ulcer disease (PUD) lowered the risk of discontinuation of TNF inhibitors (HR 0.73, 95% CI 0.55-0.97). Old age (HR 1.59, 95% CI 1.09-2.33) and prescription of inhibitors by an internist (HR 1.59, 95% CI 1.02-2.48) were associated with discontinuation of TNF inhibitors. The persistence of TNF inhibitors was 61% at 18 months. CCI score and other comorbidities were not related with early discontinuation of TNF inhibitors, while PUD was an independent contributing factor to TNF inhibitor persistence. [ABSTRACT FROM AUTHOR]

The purposes of this study are to investigate medical resource utilization and medical costs of Korean rheumatoid arthritis (RA) patients and to analyze predictors in relation to medical costs. National claims data on medical treatment were analyzed for the 151,472 RA patients in 2009. For outpatients, the mean annual number of visits was 32.5, and the mean annual total outpatient care costs were 2.0 million KRW (US$1,594) per patient. On the other hand, the mean annual length of stay of inpatients was 22.2 days, and the mean annual total inpatient care costs were 3.8 million KRW (US$3,013). Average annual total medical costs per patient for all of the RA patients were 2.9 million KRW (US$2,310). Total medical costs consisted of 26.1% outpatients' costs, 25.4% inpatient, and 48.6% medication costs, making medication costs a predominant cost driver. In the multiple regression analysis, biologic use was an important cost factor in relation to the annual total medical costs. This study provides information on the cost of illness of RA with the population-based representative RA patients in Korea, which had not been reported until now. [ABSTRACT FROM AUTHOR]

The aim of this study is to examine the validity of the rheumatoid arthritis (RA), disease activity score (DAS), 28-C-reactive protein (CRP), the simplified disease activity index (SDAI), and the clinical disease activity index (CDAI) against the DAS28-erythrocyte sedimentation rate (ESR) and determine cut-off values for each tool in Korean patients with RA. A total of 223 RA patients were consecutively recruited from the Hanyang University Hospital for Rheumatic Diseases in Seoul, Korea. DAS28-CRP, SDAI, and CDAI were measured and compared with DAS28-ESR. The correlation coefficients of DAS28-ESR with DAS28-CRP, SDAI, and CDAI were 0.93, 0.85, and 0.84, demonstrating strong linear relationships. The cut-off values of DAS28-CRP classifying RA patients into four categories of disease activity were defined as 2.19, 2.60, and 4.07. SDAI cut-off values were defined as 3.75, 7.50, and 16.88. CDAI cut-off values were defined as 3.62, 7.38, and 16.50. DAS28-CRP, SDAI, and CDAI are valid and sensitive assessment indices of disease activity that are comparable to DAS28-ESR. The cut-off values of each tool derived in this study might be useful for routine monitoring and therapeutic decision-making in Korean RA patients. [ABSTRACT FROM AUTHOR]

TNF inhibitors are being used in a rapidly expanding number of rheumatoid arthritis (RA) patients due to their effectiveness and acceptable safety profiles. To date, concerns regarding the adverse effects of TNF inhibitors have focused on infections, hematologic malignancies, and demyelinating disorders. Recently, the development of autoantibodies and other autoimmunity has been increasingly reported. Here, we describe a 36-year-old RA patient in whom organizing pneumonia and systemic lupus erythematosus were detected during etanercept treatment. [ABSTRACT FROM AUTHOR]

Rheumatoid arthritis (RA) patients with chronic kidney failure are intolerant to most disease-modifying antirheumatic drugs (DMARDs) and NSAIDs due to their potential toxicities. Although the tumor necrosis factor (TNF) inhibitors have emerged as a highly effective treatment for RA, their safety and efficacy in RA patients with chronic kidney failure have not been well reported. We retrospectively evaluated the safety and efficacy of etanercept treatment in RA patients with chronic kidney failure. We describe three RA patients with chronic kidney failure who had been treated with DMARDs, steroids and NSAIDs, but were discontinued from these classical agents due to several side effects and nephrotoxicity. The patients were treated with 25 mg of etanercept once or twice a week. We evaluated disease activity and used decreasing renal function and increasing number of infections to monitor safety. All three patients improved after starting etanercept treatment and their steroid requirements were decreased. Linear relationships between Modification of Diet in Renal Disease study equation (MDRD) glomerular filtration rate (GFR) and time were observed. Thus, in all patients, the changes in GFR did not represent superimposed acute drug toxicity, but rather chronic progressive renal failure. These cases show that etanercept may be a safe and effective treatment option for RA patients with chronic kidney failure.